US 6,485,500 B1 · Emboli protection system

Abstract

The emboli protection system provides one or more inflatable blocking balloons for isolation of a section of a blood vessel to prevent migration of emboli from the section during an interventional procedure, and fluid infusion and evacuation ports for flushing emboli from the isolated section. One embodiment provides for a distal blocking balloon catheter, over which an interventional device can be introduced, and a proximal blocking balloon catheter to be introduced over the interventional device for isolating a portion of a blood vessel to be treated. The blocking balloons can be perforated to provide the infusion ports, and thrombolytic inflation fluid may be used to break down and dissolve thrombus and plaque in the isolated portion of the blood vessel. The interventional therapeutic device such as an angioplasty balloon catheter may be incorporated into the distal blocking balloon catheter, or the distal and blocking proximal balloon catheters can be incorporated with the interventional therapeutic device together in one device. Infusion ports may also be provided in either or both of the distal and proximal blocking catheters.

Claims39

Dependent claims

An emboli protection system for isolating a portion of a blood vessel having a target site to be treated by an interventional procedure to prevent migration of emboli into the rest of the vasculature, comprising:

a distal blocking balloon catheter having distal and proximal ends, said distal blocking balloon catheter having a shaft with an inflatable balloon mounted on the shaft near the distal end of the catheter, the shaft having at least one lumen for a guide wire and at least one lumen for fluid communication with the inflatable balloon, and the inflatable balloon of the distal blocking balloon catheter having a surface defining a plurality of perforations facing the proximal end of the catheter;
a proximal blocking balloon catheter adapted to be introduced in the vasculature over said distal blocking balloon catheter, said proximal blocking balloon catheter having distal and proximal ends, said proximal blocking balloon catheter having a shaft with an inflatable balloon mounted on the shaft near the distal end of the catheter, the shaft having at least one lumen for a guide wire and at least one lumen for fluid communication with the inflatable balloon, and the inflatable balloon of the proximal blocking balloon catheter having a surface defining a plurality of perforations facing away from the proximal end of the proximal blocking balloon catheter, the shaft of said proximal blocking balloon catheter including at least one exit port and a lumen connected to said exit port for fluid communication with the interior lumen of the isolated portion of the blood vessel;
and
an inflation fluid supply connected in fluid communication with said inflatable balloons of said distal and proximal blocking balloon catheters for supplying inflation fluid to said inflatable balloons under pressure, whereby said inflation fluid exits the perforations and flushes emboli in the isolated portion of the blood vessel through the exit port of the proximal blocking balloon catheter and proximally through the fluid communication lumen of the proximal blocking balloon catheter.

1 more element

An emboli protection system for isolating a portion of a blood vessel to be treated by an interventional procedure to prevent migration of emboli into the rest of the vasculature, comprising:

a blocking balloon catheter having distal and proximal ends, said blocking balloon catheter having a shaft with a distal inflatable balloon mounted on the shaft near the distal end of the catheter, the shaft having at least one lumen for a guide wire and at least one lumen for fluid communication with the inflatable balloon, and the inflatable balloon of the blocking balloon catheter having a surface defining a plurality of perforations facing the proximal end of the catheter;
an interventional therapeutic device mounted on said shaft of said blocking balloon catheter proximal to said distal inflatable balloon;
a proximal inflatable balloon mounted on the shaft proximal to said interventional device, and the proximal inflatable balloon having a surface defining a plurality of perforations facing away from the proximal end of the blocking balloon catheter, the shaft of said blocking balloon catheter including at least one exit port and a lumen connected to said exit port for fluid communication with the interior lumen of the isolated portion of the blood vessel;
and
an inflation fluid supply connected in fluid communication with said distal and proximal inflatable balloons for supplying inflation fluid to said inflatable balloons under pressure, whereby said inflation fluid exits the perforations and flushes emboli in the isolated portion of the blood vessel through the exit port of the shaft of the blocking balloon catheter and proximally through the fluid communication lumen connected to the exit port.

2 more elements

A method for removing emboli during arteriovenous interventional procedures for treatment of a target site of a portion of a blood vessel in the vasculature, comprising the steps of:

providing a distal blocking balloon catheter having a shaft and a distal inflatable balloon mounted thereon, the distal inflatable balloon having a surface defining a plurality of perforations facing the proximal end of the catheter, and a proximal blocking balloon catheter adapted to be disposed over said distal blocking balloon catheter, said proximal blocking catheter having a shaft and a proximal inflatable balloon mounted thereon, the proximal inflatable balloon having a surface defining a plurality of perforations facing away from the proximal end of the proximal blocking balloon catheter, and said proximal blocking catheter having an exit port and a lumen connected to said exit port for fluid communication with the interior lumen of the portion of the blood vessel;
placing a guide wire across a target site in the blood vessel in the vasculature;
threading the distal blocking balloon catheter over the guide wire and positioning the distal inflatable balloon distal to the target site;
providing an interventional device for performing an interventional procedure at the target site;
threading said interventional device over the shaft of the distal blocking balloon catheter and positioning said interventional device at the target site;
threading the proximal blocking balloon catheter over the interventional device and positioning the proximal inflatable balloon proximal to the target site;
initially inflating the distal and proximal inflatable balloons simultaneously with an inflation fluid to block blood flow through the portion of the blood vessel to isolate the target site area from surrounding vasculature;
inflating the distal and proximal inflatable balloons to cause the inflation fluid to stream out of the balloon perforations, whereby fluid supplied to the inflatable balloons of the distal and proximal blocking balloon catheters exits the perforations and flushes emboli in the isolated portion of the blood vessel through the exit port of the proximal blocking balloon catheter and proximally through the fluid communication lumen of the proximal blocking balloon catheter;
performing the interventional procedure;
removing the interventional device;
and
increasing fluid pressure inside the proximal and distal inflatable balloons to increase flow and pressure within the blocked section and remove emboli from the blocked section through the exit port of the proximal blocking balloon catheter.

9 more elements

a blocking balloon catheter having distal and proximal ends, said blocking balloon catheter having a shaft with a distal inflatable balloon mounted to the catheter shaft near the distal end of the catheter, and a proximal inflatable balloon mounted to the catheter shaft, the shaft having at least one lumen for a guide wire and at least one lumen for fluid communication with the distal and proximal inflatable balloons, the shaft having a surface defining at least one evacuation port between the distal and proximal balloons and an evacuation lumen connected in fluid communication with said at least one evacuation port for removing emboli through the proximal end of the catheter, and at least one of the distal and proximal inflatable balloons having a surface defining a plurality of perforations facing toward said at least one evacuation port;
and
an inflation fluid supply connected in fluid communication with said distal and proximal inflatable balloons for supplying inflation fluid under pressure to said inflatable balloons under pressure for inflating said distal and proximal balloons in the blood vessel on either side of the target site to be treated, thereby isolating the portion of the blood vessel, and whereby said inflation fluid exits said perforations and flushes emboli in the isolated portion of the blood vessel through the evacuation port of the blocking balloon catheter and proximally through the evacuation lumen of the blocking balloon catheter.

An emboli protection system for isolating a portion of a blood vessel having a target site to be treated by an interventional procedure and for dissolving and removal of thrombus, stenotic or embolic material, comprising:

a blocking balloon catheter having distal and proximal ends, said blocking balloon catheter having a shaft with a distal inflatable balloon mounted to the catheter shaft near the distal end of the catheter, and a proximal inflatable balloon mounted to the catheter shaft, the shaft having at least one lumen for a guide wire and at least one lumen for fluid communication with the distal and proximal inflatable balloons, the shaft having a surface defining at least one evacuation port between the distal and proximal balloons and an evacuation lumen connected in fluid communication with said at least one evacuation port for removing emboli through the proximal end of the catheter, said distal inflatable balloon having a surface defining a plurality of perforations facing the proximal end of the catheter, and said proximal inflatable balloon having a surface defining a plurality of perforations facing away from the proximal end of the catheter;
and
a thrombolytic inflation fluid supply connected in fluid communication with said distal and proximal inflatable balloons for supplying inflation fluid under pressure to said inflatable balloons under pressure for inflating said distal and proximal balloons in the blood vessel on either side of the target site to be treated, thereby isolating the portion of the blood vessel, and whereby said inflation fluid exits said perforations and flushes emboli in the isolated portion of the blood vessel through the evacuation port of the blocking balloon catheter and proximally through the evacuation lumen of the blocking balloon catheter, and to thereby break down and dissolve any thrombus and plaque in the isolated portion of the blood vessel through both a chemical effect of the thrombolytic inflation fluid, and flow of the thrombolytic inflation fluid in the isolated portion of the blood vessel.

A method for isolating a portion of a blood vessel in the vasculature, the blood vessel having a target site to be treated by an interventional device, comprising the steps of:

providing a catheter shaft having a proximal end connectable to the vasculature by a hemostatic valve having a removable connector, said catheter shaft having an inflatable balloon mounted on the distal end of the catheter shaft, said inflatable balloon having a surface defining a plurality of perforations in the balloon facing the proximal end of the shaft, said shaft having at least one lumen for fluid communication with the distal balloon, and an inflation valve disposed in the said catheter shaft allowing for inflation and deflation of the balloon;
connecting the catheter shaft to the vasculature by the removable connector;
introducing the catheter shaft into the vasculature and across the target site in the blood vessel and positioning the inflatable balloon distal to the target site;
inflating the inflatable balloon with an inflation fluid supplied to the inflatable balloon under a minimum pressure to block blood flow through the portion of the blood vessel;
removing the removable connector from the hemostatic valve, said inflation valve operating to maintain a minimum pressure in the distal inflation balloon enabling said balloon to remain inflated when the removable connector is removed from the hemostatic valve;
threading an interventional device over the catheter shaft through the hemostatic valve and positioning the interventional device at the target site;
and
increasing the pressure of the inflation fluid supplied to the inflatable balloon to cause the inflation fluid to stream out of the balloon perforations and to flow proximally of said inflatable balloon through the vasculature.

5 more elements

Dependencies are inferred from the claim text.

Emboli protection system

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Emboli protection system

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Abstract

Claims39